Health Canada Ends Reconsideration Path for Priority Review and NOC/c Decisions
Health Canada has issued a new policy statement removing the possibility for sponsors to request reconsideration of certain regulatory decisions related to priority review status and advance consideration under the Notice of Compliance with conditions (NOC/c) framework.
The change came into effect on April 22, 2026 and follows a consultation launched in December 2025.
Key Policy Change
Under the updated policy, Health Canada will no longer accept requests for reconsideration of:
Rejected Priority Review requests
Rejected Advance Consideration (AC-NOC/c) requests
However, there is an important transitional provision:
Requests submitted before April 22, 2026, if rejected, remain eligible for reconsideration
Background: Accelerated Review Pathways
Health Canada offers two mechanisms to accelerate drug review timelines:
Priority Review → target review time of 180 days
AC-NOC/c pathway → target review time of 200 days
These pathways are intended for products addressing serious, life-threatening, or severely debilitating conditions.
Rationale for the Change
Health Canada states that the reconsideration process:
Requires significant internal resources
Involves re-evaluation of clinical assessment packages
Diverts resources from other drug submissions
By removing reconsideration, the agency aims to:
Improve resource allocation
Support a more efficient regulatory review process
Maintain timely access to medicines for patients
What This Means for Sponsors
For manufacturers and sponsors, this change introduces several practical implications:
1. Higher importance of first submissions
Without a reconsideration pathway, initial requests for priority review or AC-NOC/c must be robust, well-justified, and complete.
2. Shift toward resubmission strategy
Sponsors can still submit a new request with additional data:
Allowed 60 days after the original request
Must include new supporting information
Health Canada considers this route more efficient than reconsideration.
3. Increased regulatory planning pressure
Sponsors will need to:
Carefully assess eligibility criteria upfront
Strengthen clinical and regulatory justification
Align internal timelines with the 60-day resubmission window
Strategic Takeaway
This policy signals a shift toward efficiency and front-loaded regulatory quality. For sponsors, success in accelerated pathways will increasingly depend on:
Early regulatory strategy
High-quality evidence packages
Clear demonstration of unmet medical need and clinical benefit
Read the full document below.
